Frenulum spreader

ABSTRACT

An apparatus for spreading tissues. The apparatus includes a sheath member including an open end, a closed end, and a barrel extending between the open end and the closed end; and at least one flap-tip for engaging with tissues, wherein the at least one flap-tip is attached to the sheath member, each flap-tip projecting from the sheath member, wherein the at least one flap-tip is moved in response to movement of the sheath member.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional Application No.62/149,605 filed on Apr. 19, 2015, the contents of which are herebyincorporated by reference.

TECHNICAL FIELD

The present disclosure relates generally to devices for spreading oraltissue, and more specifically to devices for preventing reattachment oftissue after procedures.

BACKGROUND

A frenulum is a typically small fold of tissue that secures or restrictsmotion of a mobile organ. Several frenula exist in the human mouth, suchas the lingual frenulum under the tongue, the frenulum labii superiorisinside the upper lip, the frenulum labii inferioris inside the lowerlip, and the buccal frena which connect the cheeks to the gum. A lingualfrenulum is a fold of mucous membrane extending from the floor of themouth to the midline of the underside of the tongue. The lingualfrenulum is formed during normal embryonic development and undergoesapoptosis as the tongue develops, thereby retracting away from the tipof the tongue and increasing the tongue's mobility.

Disturbances in embryonic oral development may result in Ankyloglossia(also known as “tongue tie”), a congenital oral anomaly in which alingual frenulum connects the midline of the tongue underside with thefloor of the mouth. Ankyloglossia varies in degree of severity, frommild cases characterized by mucous membrane bands to completeAnkyloglossia, in which the tongue, attached to a lingual frenulum, istethered to the floor of the mouth.

Ankyloglossia in infants is associated with difficulties inbreastfeeding such as failure to thrive, maternal nipple damage,maternal breast pain, poor milk supply, breast engorgement, and refusingthe breast. Infants with restrictive Ankyloglossia may not be able toextend their tongues over the lower gum line to form a proper seal andmust use their jaws to keep the breast in the mouth. Ankyloglossia ininfants can lead to a range of problems, such as difficultiesbreastfeeding, speech impediments, poor oral hygiene, and socialproblems during childhood and adolescence.

The most common treatment for Ankyloglossia is a surgical proceduretermed Frenulotomy, also commonly known as Frenotomy. During thisprocedure, an incision is made several millimeters into the lingualfrenulum. The procedure is typically brief, and is usually accompaniedby minimal bleeding and discomfort. The procedure is typically madeusing surgical scissors, a scalpel, a laser source, and/or othersurgical tools. Complications of frenotomy may include infection,hemorrhaging caused by severance of the lingual artery, and asphyxiacaused by the released tongue falling back into the airway.

Following frenotomy in infants, it is recommended that the parent orother caregiver help the infant perform exercises to elevate theinfant's tongue and/or to expend a patient's lip (depending on the typeof frenotomy performed). These exercises are considered to be importantfor preventing the recurrence of tongue frenulum formation and forinducing tongue muscle function.

Current literature suggests post-frenotomy use of “active woundmanagement,” i.e., the stretching of tethered oral tissues in apatient's mouth to prevent the reattachment of a frenulum by using twofingers to be placed beside the patient's frenulum and repeatedlystretching the frenulum. The active wound management exercises aretypically performed by inserting a finger, a tongue blade, or a cottonswab into the infant's mouth and manually lifting the tongue. However,such exercises are often accompanied by discomfort for the infant andpsychological distress for the administering caregiver. In particular,parents or other individuals performing the active wound managementexercises may find the exercises difficult to handle effectively,especially in newborns when the mouth is small and delicate.

It would therefore be advantageous to provide a solution that wouldovercome the deficiencies of the prior art.

SUMMARY

A summary of several example embodiments of the disclosure follows. Thissummary is provided for the convenience of the reader to provide a basicunderstanding of such embodiments and does not wholly define the breadthof the disclosure. This summary is not an extensive overview of allcontemplated embodiments, and is intended to neither identify key orcritical elements of all embodiments nor to delineate the scope of anyor all aspects. Its sole purpose is to present some concepts of one ormore embodiments in a simplified form as a prelude to the more detaileddescription that is presented later. For convenience, the term “someembodiments” may be used herein to refer to a single embodiment ormultiple embodiments of the disclosure.

Certain embodiments disclosed herein relate to an apparatus forspreading tissues. The apparatus comprises a sheath member including anopen end, a closed end, and a barrel extending between the open end andthe closed end; and at least one flap-tip for engaging with tissues,wherein the at least one flap-tip is attached to the sheath member, eachflap-tip projecting from the sheath member, wherein the at least oneflap-tip is moved in response to movement of the sheath member.

Certain embodiments disclosed herein also relate to another apparatusfor spreading tissues. The apparatus comprises a tubular memberincluding a first open and, a second open end, and a barrel extendingbetween the first open end and the second open end; and at least oneflap-tip for engaging with tissues, wherein the at least one flap-tip isattached to the tubular member, each flap-tip projecting from thetubular member, wherein the at least one flap-tip is moved in responseto movement of the tubular member.

BRIEF DESCRIPTION OF THE DRAWINGS

The subject matter disclosed herein is particularly pointed out anddistinctly claimed in the claims at the conclusion of the specification.The foregoing and other objects, features, and advantages of thedisclosed embodiments will be apparent from the following detaileddescription taken in conjunction with the accompanying drawings.

FIG. 1 is a schematic diagram of a sheath member according to anembodiment.

FIG. 2 is a schematic diagram of a sheath member according to anotherembodiment.

FIG. 3 is a schematic diagram of a sheath member according to yetanother embodiment.

FIG. 4 is a schematic diagram of a tubular member according to anembodiment.

FIG. 5 is a schematic diagram of a tubular member according to anotherembodiment.

FIG. 6 is a schematic diagram of a tubular member according to anotherembodiment.

DETAILED DESCRIPTION

It is important to note that the embodiments disclosed herein are onlyexamples of the many advantageous uses of the innovative teachingsherein. In general, statements made in the specification of the presentapplication do not necessarily limit any of the various claimedembodiments. Moreover, some statements may apply to some inventivefeatures but not to others. In general, unless otherwise indicated,singular elements may be in plural and vice versa with no loss ofgenerality. In the drawings, like numerals refer to like parts throughseveral views.

The various disclosed embodiments include an apparatus for spreadingoral tissues and for further preventing reattachment of tissue after aseparation procedure. In particular, the disclosed embodiments may beutilized to spread a frenulum. Furthermore, the disclosed embodimentsmay be utilized to spread a frenulum following a Frenotomy procedure. Inan embodiment, the apparatus includes a sheath member including an openend, a closed end, and a barrel extending between the open end and theclosed end; and one or more flap-tip members projecting from the sheathmember.

FIG. 1 shows an example left view schematic diagram 100 of a sheathmember 110 according to an embodiment. In the example embodiment shownin FIG. 1, the right side view (not shown) of the sheath member isidentical to the left side view. In an embodiment, the sheath member 110is made of a bio-compatible material such that it can safely be insertedinto at least a human mouth.

The sheath member 110 includes an open end 120, a closed end 130, and abarrel 140 extending between the open end 120 and the closed end 130. Inan embodiment, the open end 120 is designed to fit over a caregiver'shand or portions thereof (in particular, one or more fingers), therebyallowing insertion of such hand or portion thereof into the barrel 140in order to spread one or more frenula. In particular, the sheath member110 may be designed to spread oral frenula. Such spreading using thesheath member 110 may be utilized to, for example, exercise a frenulumafter a frenotomy, thereby hindering reattachment of the frenulum. Suchexercise may further be used for spreading the frenulum in order to flexa patient's tongue and increase its movement. In the embodiment shown inFIG. 1, the barrel 140 is a roughly cylindrical component in whichportions of a caregiver's hands may be inserted.

The sheath member 110 further includes one or more flap-tips 150 affixedto the closed end 130 and/or to the barrel 140. In the embodiment shownin FIG. 1, the sheath member 110 includes flap-tips 150-1 and 150-2(hereinafter referred to individually as a flap-tip 150 and collectivelyas flap-tips 150, merely for simplicity purposes) attached to the closedend 130 and projecting freely therefrom. Each flap-tip 150 may beattached, affixed, joined, or otherwise connected to the closed end 130at a bottom end of the flap-tip 150.

In an embodiment, the flap-tips 150 are at least partially flat inshape, thereby allowing for easier insertion into a patient's mouthand/or easier operation during exercises. The flap-tips 150 may furtherbe flexible, thereby allowing a caregiver to move the flap-tips 150 byinserting one or more fingers or portions thereof into the barrel 140and moving the inserted finger(s).

The flap-tips 150 may be placed beside the frenulum in a frenotomypatient's mouth, thereby enabling a caregiver to manually lift thetongue, spread the upper lip, and/or any similar exercises or movementsof tissue. As an example, a caregiver may insert his or her fingers inthe sheath member 110 through the open end 120. The caregiver mayfurther insert one of his or her fingers near the bottoms of theflap-tips 150 via the barrel 140 and/or the closed end 130. Thereafter,the caregiver may place the flap-tips 150 into a patient's mouth,typically beneath the patient's tongue, thereby allowing spreading ofthe frenulum by moving his or her fingers. Specifically, movement of thecaregiver's finger(s) within the barrel 140 and/or against the closedend 130 may cause at least a portion of the sheath member 210 (e.g., thebarrel 140 and/or the closed end 130) to flex, bend, or move, therebycausing movement of the flap-tips 150 projecting therefrom. Thespreading and/or practicing of the frenulum increases the motion of thetongue and/or the lip. Such activity, after a frenotomy procedure,decreases the likelihood of reattachment of the frenulum. Furthermore,such activity may prevent the need for an initial or subsequent surgicalprocedure if made on a daily basis as the movement range of the frenulumis likely to increase.

In another embodiment, the flap-tip 150 and/or the closed end 130 may bedetachable and, thus, may be replaced after use. Such replacement allowsfor ensuring sterile operations while using the sheath member 110 and/orfor using different flap-tips (e.g., made of different materials, indifferent shapes, having different sizes, and so on) during differentexercise sessions.

FIG. 2 is an example schematic diagram 200 of a side view of a sheathmember 210 according to another embodiment. The sheath member 210includes an open end 120, a closed end 130, and a barrel 140 extendingbetween the open end 120 and the closed end 130. The sheath member 210includes a single flap-tip 150 that is partially split at a length 160along the flap-tip 150. In the example embodiment shown in FIG. 2, theflap-tip 150 is attached to the barrel 140. In particular, in FIG. 2,the flap-tip 150 is attached to a portion of the barrel 140 near theclosed end 130. The flap-tip 150 may be attached, affixed, joined, orotherwise connected to the barrel 140 at a bottom end of the flap-tip150 and projecting freely therefrom.

In an embodiment, at least part of the sheath member 210 is coated witha biocompatible material. In a further embodiment, the biocompatiblematerial may have soft tactile properties. The biocompatible materialmay be, but is not limited to, natural rubber, silicone,polyvinylchloride (PVC), phthalate-free PVC, latex, nylon,polyethersulfone, acrylonitrile butadiene styrene, polypropylene,polycarbonate, a Kraton polymer, a combination thereof, and the like.

In an embodiment, a light source (not shown) may be integrated in, forexample, the closed end 130. The light source may be, but is not limitedto, a light-emitting diode (LED). The light source may be directed so asto cast light on the environment around the sheath member 210. Inanother embodiment, the sheath member 210 may be made of transparentmaterial. Such transparent material may allow a light source to beintegrated within the sheath member 210 and to illuminate the sheathmember 210.

As a non-limiting use example, a caregiver may insert one or morefingers into the barrel 140 of the sheath member 210 via the open end120. Thereafter, the caregiver may move the inserted fingers within thebarrel 140 to cause movement of the flap-tip 150. In particular, thefinger movement may cause portions of the barrel to flex, bend, orotherwise move, thereby causing the flap-tips 150 projecting therefromto be moved accordingly. If a light source is integrated in the closedend 130, light may be projected into, e.g., a patient's mouth when theclosed member 130 is placed therein. The illumination may help guide thecaregiver to the portion of the mouth to be exercised. If a light sourceis integrated in the sheath member 210 and the sheath member 210 istransparent, the sheath member 210 may be illuminated, thereby allowingthe caregiver to see both the sheath member 210 and one or more portionsof the patient's mouth more easily.

FIG. 3 is an example schematic diagram 300 illustrating a side view of asheath member 310 according to yet another embodiment. The sheath member310 includes an open end 120, a closed end 130, and a barrel 140extending between the open end 120 and the closed end 130. In theembodiment shown in FIG. 3, the sheath member 310 includes only oneflap-tip 150 for, e.g., stretching a patient's frenulum.

In an embodiment, the sheath member 310 further includes a plurality oftines 170 disposed on and projecting from at least a portion of theflap-tip 150. In the example embodiment shown in FIG. 3, the tines aredisposed on and projecting freely from a top end of the flap-tip 150.Thus, when the caregiver utilizes the sheath member 310 and moves theflap-tip 150, the tines 170 come into contact with various portions ofthe patient's body (e.g., tissues in the mouth).

The tines 170 may be made of, e.g., a carrier material. The carriermaterial may include a healing material for cleaning and/or otherwisepromoting healing such as, but not limited to, an antibacterialsubstance, a sanitizing substance, a disinfectant substance (e.g.,mouthwash), and the like. In a further embodiment, the tines 170 includean anesthetic material that may be released responsive to epidermalcontact. The anesthetic material may be, but is not limited to,lidocaine, vapocoolants, eutectic mixtures of local anesthetics,formulations thereof, and the like.

FIG. 4 is an example schematic diagram 400 of a tubular member 410according to an embodiment. The tubular member 410 includes a first end420 and a second end 430. A caregiver may insert one or more fingersthrough the first end 420 into the tubular member 410, and may stretch apatient's frenulum using a flap-tip 440 attached, affixed, joined, orotherwise connected to the second end 430. In the example embodimentshown in FIG. 4, the flap-tip 440 is split such that a patient'sfrenulum may be laid thereon.

In another embodiment, the flap-tip 440 may have a two-ear shape suchthat a patient's frenulum can be laid there between. The tubular member410 is typically made at least in part of a flexible material to allow acaregiver to move the tubular member 410 and/or any portion thereof.

FIG. 5 is an example schematic diagram 500 of a tubular member 510according to another embodiment. The tubular member 510 includes aflap-tip 440 for frenulum spreading or similar exercises. The tubularmember 510 is a sheet which is curved, molded, or otherwise shaped intoa tubular shape, with a first longitudinal edge 520 and a secondlongitudinal edge 530 shaped so as to enable at least partial overlapbetween the longitudinal edges 520 and 530. When, for example, a fingeris inserted from the bottom opening 540 toward the upper opening 550,the longitudinal edges 520 and 530 may separate from a first overlappingposition to a second overlapping position, and may be further separatedto a non-overlapping position as may be necessary to accommodateinsertion of the fingers. The flap-tip 440 may be attached to, affixedto, or molded, formed, or otherwise created as a single component withthe tubular member 510 as described further herein above with respect toFIG. 4.

FIG. 6 is an example schematic diagram 600 of a tubular member 610according to another embodiment. The tubular member 610 includes aflap-tip 620 for frenulum spreading or similar exercises projectingtherefrom. In an embodiment, the tubular member 610 may be a sheet whichis curved, molded, or otherwise shaped into a tubular shape having alongitudinal spread 630 extending between a bottom opening 640 and anupper opening 650. The longitudinal spread 630 enables the insertion offingers in different sizes from the bottom opening 640 toward the upperopening 650. The flap-tip 620 may be attached to, affixed to, or molded,formed, or otherwise created as a single component with the tubularmember 610 as described further herein above with respect to FIG. 4.

It should be noted that the embodiments described herein above arediscussed with respect to a caregiver, a patient, and an oral frenulummerely for simplicity purposes and without limitation on the disclosedembodiments. The embodiments described may be utilized by any personseeking to stretch or otherwise exercise and/or spread tissue or othermaterials without departing from the scope of the disclosure. It shouldbe further noted that the Ankyloglossia correction procedure, alsocommonly known as Frenotomy, may be executed using the apparatus asdescribed herein above.

It should be further noted that components of the embodiments describedherein above may be made of the same material or made of differentmaterials. For example, the closed end 130 and/or flat-tip 150 may bemade of natural rubber, while the open end 120 may be made of silicone.Additionally, different portions of a component may be made of differentmaterials. For example, an outer portion of the open end 120 may be madeof a biocompatible material, while an inner portion of the open end 120may be made of a non-biocompatible material or a different biocompatiblematerial.

It should further be noted that portions of the embodiments describedherein above may be molded together or otherwise created as a singlepart, or may be created as separate parts and affixed. Any or all of thecomponents may be made of flexible material to allow for ready operationby, e.g., a caregiver.

All examples and conditional language recited herein are intended forpedagogical purposes to aid the reader in understanding the principlesof the disclosed embodiment and the concepts contributed by the inventorto furthering the art, and are to be construed as being withoutlimitation to such specifically recited examples and conditions.Moreover, all statements herein reciting principles, aspects, andembodiments of the disclosed embodiments, as well as specific examplesthereof, are intended to encompass both structural and functionalequivalents thereof. Additionally, it is intended that such equivalentsinclude both currently known equivalents as well as equivalentsdeveloped in the future, i.e., any elements developed that perform thesame function, regardless of structure.

What is claimed is:
 1. An apparatus for spreading tissues, comprising: asheath member including an open end, a closed end, and a barrelextending between the open end and the closed end; and at least oneflap-tip for engaging with tissues, wherein the at least one flap-tip isattached to the sheath member, each flap-tip projecting from the sheathmember, wherein the at least one flap-tip is moved in response tomovement of the sheath member.
 2. The apparatus of claim 1, wherein theat least one flap-tip has a length, wherein the at least one flap-tip issplit at least partially along the length.
 3. The apparatus of claim 1,further comprising: a plurality of tines attached to the at least oneflap-tip.
 4. The apparatus of claim 3, wherein the plurality of tinesare made from at least a carrier material.
 5. The apparatus of claim 4,wherein the carrier material includes an anesthetic material, whereinthe anesthetic material releases in response to epidermal contact. 6.The apparatus of claim 4, wherein the carrier material includes ahealing material, wherein the healing material releases in response toepidermal contact.
 7. The apparatus of claim 1, wherein the sheathmember is transparent, further comprising: a light source disposedwithin the sheath member.
 8. The apparatus of claim 1, wherein the atleast one flap-tip is detachable from the sheath member.
 9. Theapparatus of claim 1, wherein the apparatus is utilized for a stretchingoral frenula procedure.
 10. An apparatus for spreading tissues,comprising: a tubular member including a first open, a second open end,and a barrel extending between the first open end and the second openend; and at least one flap-tip for engaging with tissues, wherein the atleast one flap-tip is attached to the tubular member, each flap-tipprojecting from the tubular member, wherein the at least one flap-tip ismoved in response to movement of the tubular member.
 11. The apparatusof claim 10, wherein the at least one flap-tip is attached to the secondopen end.
 12. The apparatus of claim 10, wherein the at least oneflap-tip has a length, wherein the at least one flap-tip is split atleast partially along the length.
 13. The apparatus of claim 10, furthercomprising: a plurality of tines attached to the at least one flap-tip.14. The apparatus of claim 13, wherein the plurality of tines are madefrom at least a carrier material.
 15. The apparatus of claim 14, whereinthe carrier material includes an anesthetic material, wherein theanesthetic material releases in response to epidermal contact.
 16. Theapparatus of claim 14, wherein the carrier material includes a healingmaterial, wherein the healing material releases in response to epidermalcontact.
 17. The apparatus of claim 10, wherein the tubular member istransparent, further comprising: a light source disposed within thetubular member.
 18. The apparatus of claim 10, wherein the at least oneflap-tip is detachable from the tubular member.
 19. The apparatus ofclaim 10, wherein the barrel further includes a sheet having a firstlongitudinal edge and a second longitudinal edge, the first longitudinaledge and the second longitudinal edge having at least one overlappingposition and a non-overlapping position.
 20. The apparatus of claim 10,wherein the apparatus is utilized for a stretching oral frenulaprocedure.